Package 59651-539-05

Brand: isosorbide mononitrate

Generic: isosorbide mononitrate
NDC Package

Package Facts

Identity

Package NDC 59651-539-05
Digits Only 5965153905
Product NDC 59651-539
Description

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-539-05)

Marketing

Marketing Status
Marketed Since 2022-11-07
Brand isosorbide mononitrate
Generic isosorbide mononitrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "55810c9d-1140-40b8-a297-210a84afc05a", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["LX1OH63030"], "rxcui": ["311196", "317110", "353538"], "spl_set_id": ["55810c9d-1140-40b8-a297-210a84afc05a"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-539-01)", "package_ndc": "59651-539-01", "marketing_start_date": "20221107"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-539-05)", "package_ndc": "59651-539-05", "marketing_start_date": "20221107"}], "brand_name": "ISOSORBIDE MONONITRATE", "product_id": "59651-539_55810c9d-1140-40b8-a297-210a84afc05a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "59651-539", "generic_name": "ISOSORBIDE MONONITRATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOSORBIDE MONONITRATE", "active_ingredients": [{"name": "ISOSORBIDE MONONITRATE", "strength": "30 mg/1"}], "application_number": "ANDA216557", "marketing_category": "ANDA", "marketing_start_date": "20221107", "listing_expiration_date": "20261231"}